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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Proportional processes can sometimes be the answer to a few (apparently competing) problems0

 

But they shouldn’t equate to abridged consideration

Dr Gary Allen | AHRECS senior consultant | Profile
Professor Mark Israel 
| AHRECS senior consultant | Profile
Professor Colin Thomson AM
 | AHRECS senior consultant | Profile

 

There are three things that we have consistently found when we have conducted desktop audits of human research ethics arrangements:

  1. Researchers believe the manner in which their interactions with their institution’s human research ethics arrangements are being treated is disproportional to the real risks and ethical sensitivity of their work. Symptoms include delays waiting for the next meeting of the research ethics committee and lengthy forms, which seem excessive for a project that might be following the well-established practice in a discipline. For busy researchers, this seems to confirm their suspicion that the research ethics committee is indifferent to the nature and value of the project and the process is about policing their conduct and catching them in wrongdoing. This perception can be especially acute in disciplines other than those in health sciences and clinical trials and is particularly prevalent for participant-directed designs. We have written about the dangers of this adversarial climate (Israel et al., 2016), and as consultants have advised many research institutions on how to tackle it.
  2. Research ethics committees(and research office staff) talk of being overwhelmed with work (and sometimes paper), struggling to find time to focus properly on the most risky and ethically challenging projects, and being left with insufficient resources to conduct professional development or other constructive activities that could improve ethical practice (design, review, conduct or reporting). One of the common complaints of review bodies who are overwhelmed by their workload is that matters would be improved if more researchers were more familiar with and understood the requirements and submitted better applications.

Reviewers and researchers commonly point to the other as the source of the problem and insist only change to the other party’s attitudes will fix the ‘ethics problem’.

The irony is that a suite of related strategies can fix both these behaviours. Rather than one party changing and the other ‘prevailing’, if both change cooperatively and the functioning of human research ethics arrangements shifts to a more positive approach, the process can facilitate research and achieve the objective of resourcing reflective practice.

This article is not about a proportional research ethics review arrangement (a piece on that will be in the Research Ethics Monthlyincluding discussion about constructive review feedback). Instead, this piece is about proportional processes, which complement research ethics review. And, this is linked with our third finding.

  1. Institutional risk concerns appear to be associated with any delegation of these matters to a process outside of the research ethics committee.

Those processes relate to the consideration of:

  1. applicant responses to review feedback,
  2. ethical conduct reports, and
  3. variation requests.

Figure 1 This image (without the watermark) is available to USD3+ Patrons https://www.patreon.com/posts/27638074

The default position for consideration on those matters should be processing outside the research ethics committee, such as panel review (a small group of committee members via email), executive review (by the Chairperson or Deputy Chairperson) or administrative review. Full research ethics committee review should be reserved for the most risky and ethically sensitive of projects.

In our experience, it is common for institutions to include these items on the research ethics committee agenda. The purpose of this can be unclear: is it for ratification or notification? And are all committee members expected to consider these? In our view, this is often impractical: these matters typically need to be considered in the context of the whole project, a context that committee members cannot be expected to retain or revisit. Provided adequate records of the panel or executive consideration are kept, committee agendas may need to include these items only when the ethics consideration merits committee consideration.

AHRECS has been able to assist clients to define triggers for the processing pathways, stage transition towards the ultimate delegated review and establish the required record keeping. We have also assisted small/early journey institutions to set thresholds (soft and hard) that would trigger transitioning from the point at which all matters are considered by the research ethics committee to the implementation of delegated processing. In this way, change is proactive and stays ahead of the predictable rise in workload.

In the AHRECS subscribers’ area, USD10+ Patrons can access suggested criteria for the delegated processing of (b) and (c) from the list above.

If implemented correctly, this approach should help:

  1. Researchersperceive the process as far more relevant, reasonable and client focussed. They also should have a clearer appreciation of the triggers for higher review.
  2. Research ethics committees have more time and capacity to concentrate on genuinely risky cases, to be involved in professional development and to formulate policies and resources.
  3. Institutional risk concerns are alleviated by having transparent criteria for escalated consideration and reduced reasons for researchers to avoid the processes.

Reference

Israel, M, Allen, G & Thomson, C (2016) Australian Research Ethics Governance: Plotting the Demise of the Adversarial Culture. In van den Hoonaard, W & Hamilton, A (eds) The Ethics Rupture: Exploring Alternatives to Formal Research-Ethics Review. Toronto: University of Toronto Press. pp285-316.ISBN 9781442626089 http://www.utppublishing.com/The-Ethics-Rupture-Exploring-Alternatives-to-Formal-Research-Ethics-Review.html

Commentary

Dr Mark Bahr, Chair of Bond University Human Research Ethics and Assistant Professor Psychology

Communication is the key to much of what we do in any part of our lives. Much of the time what is said and what is heard are very different things… communication and a shared understanding of our roles in reviewing and conducting research is vital, and as indicated often misunderstood through the lens of our role. There is a clear need to establish trust at the three levels indicated in the article. Where there is a reasonable understanding of the role of each group, institutional risk managers, research ethics committees and researchers there is plenty of scope for alternate models of review for certain types of low-risk review. For example, where research methods are being taught using authentic assessment methods with clearly defined limits there is scope for flexible review especially when a process is in place for escalation to a greater level of scrutiny when called for.

One difficulty with all review is the evaluation of risk, it is clear that we each appreciate risk differently. Appreciation of risk in the study and indeed the benefit of the study varies with the beholder. There is no intrinsic issue with proportional approaches but the setting of thresholds is an important consideration. One of the concerns I would have in perhaps the intermediate-term is that what starts off as a flexible framework with responsive settings, over time tends to drift towards rigidity. We need to be vigilant that we don’t drift in that direction.

Shara Close, Manager, Research Integrity & Ethics, Charles Darwin University

Broadly from my experience over the last five-plus years working in the research integrity and ethics space – both pre- and post-implementation of proportional review – the introduction of expedited review processes and streamlining of the administrative functions associated with HREC review has drastically shifted attitudes and the ‘adversarial climate’ associated with ethics review at the University. Colleagues joining the University post-implementation have commented on how peculiar it is to find such positive attitudes towards ethics review. We now find ourselves focusing on more nuanced issues regarding improving engagement with researchers and improving applications in an effort to increase the number of high-quality applications that are ‘approved first go’ or with only very minor adjustments.

Laura Thorncraft, Research Ethics Coordinator, Charles Darwin University

Our proportional process gives researchers a sense of choice and control over the review of their proposals. The researcher nominates the risk level and justifies the risks, so they make a case for proportional review that is treated seriously by research admin staff. It’s relatively rare that proposals are escalated. I think this feeds into the article’s first point about perceptions and adversarial relationships, and something that we do quite well.

This post may be cited as:
Allen, G., Israel, M. & Thomson,  C. (23 July 2019) Proportional processes can sometimes be the answer to a few (apparently competing) problems. Research Ethics Monthly. Retrieved from: https://ahrecs.com/human-research-ethics/proportional-processes-can-sometimes-be-the-answer-to-a-few-apparently-competing-problems

Professional Development across the Term of an HREC Committee Member0

 

AHRECS has considerable experience working with universities, hospitals, research institutions, government and non-government organisations to care for and build the capacity of its HREC Committee members across the entire term of their appointment. We start with the needs of our clients and offer support from recruitment all the way through to running an exit interview.

Many HRECs have quite simple manual-based inductions; we help HRECs to create something more welcoming and interactive that takes members from first contact to the point where they can contribute effectively to a committee. There is a significant difference between delivering a single ‘training session’ and creating a suite of professional development activities over two to three years, that covers committee members’ terms, and that might include dedicated annual PD and Strategy sessions and incorporate ongoing PD into each HREC meeting.

We can:

  • help recruit expert external members to meet the needs of specific HRECs
  • create interactive and multi-media induction and orientation materials
  • introduce members to the broader literature on research ethics
  • create material and run professional development sessions tailored to the specialist roles of particular HRECs
  • evaluate the performance of the HREC and provide feedback to the HREC and its host institution
  • offer exit interviews to HREC members stepping down from their role, and then….
  • help recruit replacement members to HRECs

We have provided elements of such services in Australia, Canada, Mauritius, New Zealand, Taiwan, United Kingdom, United States and Vietnam for new and established, small and large institutions and consortia of research organisations.

Contributor
Prof. Mark Israel, AHRECS senior consultant
AHRECS profile page
mark.israel@ahrecs.com

This post may be cited as:
Israel M. (2017, 22 June) Professional Development across the Term of an HREC Committee Member. Research Ethics Monthly. Retrieved from: https://ahrecs.com/services/professional-development-across-term-hrec-committee-member

Research Ethics in the Philippines: a personal journey0

 

My recall of the earliest encounter I had with research ethics is when, as a newly appointed faculty member of the department of obstetrics and gynecology of the College of Medicine (CM) of the University of the Philippines (UP) and concurrent attending at the Philippine General Hospital (PGH), I rushed to the office of the ethics research committee (known as the Research Implementation and Development Office or RIDO) of CM before the end of office hours one Friday. In my hand was a letter, addressed to the then chairman requesting approval of a study I was about to conduct. Attached to the letter was a one page synopsis of the research protocol. I was fortunate enough to catch him on his way out of the office, and doubly lucky he agreed to quickly browse through the papers I pushed in front of him. He then instructed the office secretary to stamp the letter “APPROVED”, and proceeded to affix his signature. It was in the early 1990’s!

His stamp of approval went a long way towards legitimizing the outcome of my research. I was able to collect and isolate N. gonorrhoea from commercial sex workers in Manila and Cebu, freeze dried all 92, and transport them hand-carried to the laboratory of at the University of Washington. It turned out, almost all the isolates were resistant to the standard first line drug (ciprofloxacin) at that time. Interestingly, a few months before, my collaborator from the US walked into our office looking for someone to work with. Apparently, a US male citizen had been diagnosed to have ciprofloxacin resistant gonorrhea infection. He admitted to having paid sex in Manila and Cebu prior to flying back home. Fate would have it that I was in the office when my collaborator walked in. And since my sub-specialty in obstetrics and gynecology is in infectious disease, the rest was history. I am including this in my narrative because ordinarily, researches with no international collaboration and/or funding would not warrant a mandatory ethics research committee approval. If the process I went through at that time could be construed as a legitimate one today!

Soon after I finished the gonorrhea study, I found myself being appointed by our department chairman to be the representative to the same ethics research committee (RIDO)! By then, in the early years of 1990, all basic science departments of CM and all clinical departments of PGH appointed representatives to RIDO. Meetings were conducted almost monthly to discuss and evaluate research protocols of faculty members who cared to submit their protocols. In those early times, these usually were those with external funding such as clinical trials, or those with international collaborations. I seem to remember the chair of RIDO would present a brief summary of the protocol at hand for the consideration of the members present. If there were no major objections, the research protocol gets approved, and the study will proceed. There didn’t exist written guidelines and standard operating procedures for RIDO. That was in the later years of 1990 and early years of 2000.

When the chair of RIDO retired from the College of Medicine, she recommended me as her replacement. By then, the beginnings of guidelines and standard operating procedures have been put in place. The developments in the interest and commitment to research ethics were being fueled not only within the walls of the academe (CM, PGH and UP), but also in the scientific community. The creation of the National Institutes of Health in UP Manila, whose mandate is to spearhead research at par with the international community, played a big role in upgrading the standards of research, and along with it, compliance to international standards of conducting ethical review of research involving human participants. A Fogarty International grant to UP Manila, whose prime mover was Professor Leonardo D. de Castro, PhD of the College of Social Science and Philosophy of UP Diliman, made it possible to create training programs which empowered the academe in bioethics. In fact in the early years of 2000, a Diploma course in Bioethics was approved and offered through the collaborative efforts of UP Manila and Diliman campuses. Unwittingly, for what I consider to be totally less noble reasons, I took the Diploma course. My main reason was not to help promote research ethics specifically. It was really more for my professional development. At that time, I was already a tenured faculty member. But the trend in the academe was for younger members, even though not yet tenured, to proceed to obtain masteral and even doctoral degrees. My thought at that time was I didn’t want to be upended by younger colleagues. So I enrolled and finished the Diploma course in Bioethics. A year thereafter, the full Masteral course was approved and offered. I proceeded to re-enroll for the same main reason and motivation. It took me several years and 3 extensions of the maximum residency rules of the University before I was able to finish and defend my thesis, and get my Masteral degree in Bioethics!

The prime movers of the bioethics program UP Manila were from the College of Medicine headed jointly by Dra Marita Reyes and Dra Cecilia Tomas. Equal collaborators of the program were Professor Leonardo D. de Castro of the Department of Philosophy, College of Social Science and Philosophy in UP Diliman, among others. The multi-disciplinary collaboration made it possible for many others to establish the Social Medicine Unit (SMU) of the College of Medicine to administer to the MS Bioethics program. It also paved the way for the establishment of a coordinated and integrated system of research ethics review in UP Manila, called the UP Manila Research Ethics Board (UPMREB).

The UPMREB created several panels, each one practically a research ethics committee, with jurisdiction over various sectors of UP Manila: faculty of the College of Medicine (who conduct most of the basic and clinical trials); resident and fellow doctors of Philippine General Hospital; and faculty and students of the various other colleges. Using the same guidelines and standard operating procedures, all the panels of the UPMREB are able to review, approve and monitor all researches in UP Manila. It was also around this time, after my few years as chair of RIDO, that intense preparations were made for the accreditation of RIDO by the Forum for Ethics Research Committees in the Asia Pacific (FERCAP). With the efforts of Dra Evangeline Santos, professor of Ophthalmology and co-graduate of mine from the Diploma in Bioethics program, assisted by other staff of the College of Medicine, FERCAP accreditation was achieved. Subsequently, UPMREB and all its panels achieved the same accreditation.

In the meantime, a law (Republic Act No. 10532), called the Philippine National Health Research System (PNHRS) was enacted in May 2013 to coordinate and integrate all stakeholders in health research in the Philippines. It is through the force of this law that the scientific community outside the University through the Department of Science and Technology (DOST) of the Philippine government, in collaboration with the Department of Education and Culture through the Commission on Higher Education (CHED) and the Department of Health, asked the NIH of UP Manila to implement a Memorandum Order which mandates that all research involving human participants shall undergo review by accredited ethics research committees (by December 2015). The DOST, through the Philippine Council for Health Research and Development (PCHRD), designated the Philippine Health Research Ethics Board (PHREB) as the policy-making body with regards to the establishment, registration, accreditation and regulation of research ethics committees in the country. Henceforth, all academic institutions, all hospitals and health care facilities, and all entities doing health and health-related research involving human participants should submit their studies to PHREB-accredited research ethics committees for review, approval and monitoring. The main objectives are to assure that research participants are not harmed (but benefitted), and that research outcomes are credible.

The PHREB, under the chairmanship of Professor Leonardo D. De Castro, created two important committees: 1). Committee on Information Dissemination, Training and Advocacy (CIDTA); and 2). Committee on Standards and Accreditation (CSA). CIDTA was initially chaired by Dra Rosario Tan-Alora, professor of internal medicine, bioethics and former dean of the college of medicine in the University of Santo Tomas. I had the privilege of being a member of her committee, which conducted trainings for nearly all hospitals and academic institutions in the country. Trainings programs were on Basic Research Ethics, on Good Research Practice, and on Standard Operating Procedures. The objective was to enable participants to create and work in research ethics committees of their respective institutions, be they hospitals or academes. Very recently, Dra Alora decided to turn over the chairmanship of CIDTA to me, although she continues to be an invaluable member/mentor. And more recently, CIDTA is preparing to embark on including a Good Clinical Practice module among its training programs.

The other committee (CSA), initially chaired by Dra Cecilia Tomas, has been in charge of setting standards for research ethics committees all over the country, registering them, and assessing them for accreditation. Three levels of accreditation have been established by CSA: Level 1 are research ethics committees capable of reviewing all types of protocols, except clinical trials; Level 2 are research ethics committees capable of reviewing even clinical trials but not those for products intended for registration with the Philippine Food and Drug Administration (FDA). Both committees had been busy the past 2 years. From a few accredited research ethics committees a couple of years ago, there are now 72 all over the country, many of them Level 3! (See http://ethics.healthresearch.ph for a complete listing)

The Philippine Council for Health Research and Development (PCHRD), recognizing the existence of research projects whose proponents may not be affiliated with institutions with accredited research ethics committees, and in fact providing funds for some such projects, reactivated the National Ethics Committee (NEC). Chaired by Dra Marita Reyes, the NEC is essentially a research ethics committee composed of multi-sectoral recruited volunteers, myself recently included representing the medical field, which reviews research proposals referred to it by the Department of Health and PCHRD. In 2011, the PHREB published the National Ethical Guidelines for Health Research, providing written, country-specific guidelines on the ethical conduct of researches on various fields. (See nec.pchrd.dost.gov.ph). Currently, a technical working group headed by Dra Marita V.T. Reyes, with me as one of the members, is in the final stages of updating the guidelines for 2017!

My personal journey in the world of research ethics continues in my newly-assigned tasks of handling classes in the MS Bioethics graduate program, specifically handling Research Ethics and Research Ethics Review classes. From the one-man, practically ambush approval of my very first international research collaboration, to the current legislated and well-established research ethics system, I have been a privileged witness, albeit by twists of fate more than intent design on my part in many instances, to the evolving developmental history of research ethics in the Philippines. This narration is by no means the complete accurate picture. It is a humble and modest attempt to share a part of my career in the academe as a professional doctor taking care of patients, teaching younger colleagues, doing research on the side, and performing administrative functions.

I am grateful to Dr Gary Allen for the opportunity.

Submitted 16 April 2017.
Revised 24 April 2017 after obtaining permission (and more accurate inputs) from the persons whose names were included in the article.

Contributor
Ricardo Manalastas, Jr., MD, MSc (Bioethics) is a professor of Obstetrics & Gynecology, Infectious Diseases and Bioethics at the College of Medicine, University of the Philippines, Manila, and Attending obstetrician gynecologist at the Philippine General Hospital.
He can be reached by email at rmmanalastasmd@me.com  | rmmanalastasmd@yahoo.com

This post may be cited as:
Manalastas R. (2017, 24 April) Research Ethics in the Philippines: a personal journey. Research Ethics Monthly. Retrieved from: https://ahrecs.com/uncategorized/research-ethics-philippines-personal-journey

A place for expedited ethics review of time-critical above-low risk research2

 

“Have you got ethics yet?” is a question asked frequently where health, social and behavioural sciences postgrads gather on campus. The amount of time human research ethics committees take to approve an application is also a common topic of conversation among university staff. Researchers often, it seems, grumble about delays in beginning their data collection while their ethics application awaits approval. As a recently retired chair of an ethics committee I confess that I rarely felt sympathy for these grumblers. Mostly, it seemed to me, they simply failed to plan their research time-line to match the clearly stated realities of the ethics application and approval process. However, I believe that ethics committees need to have in place processes which can take accommodate an important issue in need of research which has arisen unexpectedly and where data collection is time critical—such as following a disaster event where agencies need researchers to be in the field collecting data from those affected before the quality of the information is compromised with the passage of time.

Starting with the 2009 Victorian Black Saturday bushfires (173 deaths, 2029 homes destroyed) I have been involved in several post-bushfire field research interview surveys of affected householders about their pre-fire bushfire risk perceptions, plans and preparations, and their decisions and actions during the fire. The studies were conducted at the request of fire and emergency management agencies. No adverse incidents occurred. The findings have assisted agencies in reviewing and refining their community bushfire safety policies and procedures. A good case can be made that the timely information gained by the post-bushfire interview research has contributed to improved householder bushfire safety.

In the post-bushfire research where I was the chief investigator 2011 – 2014, approval of these above-low risk studies by my university’s Human Ethics Committee was speedy—within 72 hours. Each application was in the form of a modification of an originally-approved application from 2009. However, colleagues across a range of institutions have told me that it would be very difficult for them to undertake similar post-disaster research because of the time that would be required to obtain approval of such above-low risk research from their human research ethics committee. Concerned about this apparent situation, I decided to investigate how many Australian university human research ethics committees (UHRECs) had provisions for expedited review of above-low risk research.

In a collaboration with the Bushfire and Natural Hazards CRC, I sent a short survey questionnaire to all 39 Australian UHRECs in mid-2014. There were 28 responses (72%). Nine (32%) of the 28 reported having provisions for expedited review of above-low risk research; four described formal arrangements, five described ad hoc arrangements at the Chair’s discretion. Nineteen (68%) had no such provisions. Six of these 19 (32%) described possibilities if the circumstances were sufficiently compelling, the remaining 13 stated simply that they had no such provision. Six UHRECs described preferred arrangements for researchers to submit a generic application well in advance of an actual event and obtain provisional approval, and then submit a detailed application for modification when the specifics were known. A detailed report of findings is at http://www.bnhcrc.com.au/publications/biblio/bnh-1881

I believe that UHRECs which have no provisions for expedited review of above-low risk research do their institution, and the wider society, a disservice.

Jim McLennan is an adjunct professor in the School of Psychology and Public Health at La Trobe University, Melbourne. You can access Jim’s La Trobe University profile here and he can be contacted at J.McLennan@latrobe.edu.au.

This blog may be cited as:
McLennan, J. (2016, 22 February) A place for expedited ethics review of time-critical above-low risk research. Research Ethics Monthly. Retrieved from: https://ahrecs.com/uncategorized/a-place-for-expedited-ethics-review-of-time-critical-above-low-risk-research

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